CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 892—RADIOLOGY DEVICES > SUBPART B—Diagnostic Devices (§892.1000 to §892.2050) > 892.1360—Radionuclide dose calibrator.

892.1360—Radionuclide dose calibrator.

(a) Identification. A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.
(b) Classification. Class II.